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临床试验/NCT04517760
NCT04517760已完成不适用

Evaluating an HIV Risk Screening Tool for Use in a Population of Orphans and Other Vulnerable Children in Tanzania

Elizabeth Glaser Pediatric AIDS Foundation1 个研究点 分布在 1 个国家目标入组 21,080 人开始时间: 2018年2月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
21,080
试验地点
1
主要终点
Specificity of HIV risk screening tool

研究概览

简要总结

The goal of the research was to evaluate the performance of items within the Kizazi Kipya (K2) Orphan and Vulnerable Children (OVC) HIV risk screening tool in identifying HIV-positive children, to optimize an HIV screening tool for OVC and children and adolescents in facility settings and to assess the feasibility and acceptability of home-based HIV risk screening and testing.

详细描述

Under the ongoing community-based Kizazi Kipya (K2) OVC project, program staff currently administer a 13-item HIV risk screening tool to all K2 program beneficiaries, and refers those who screen positive to facility-based HIV testing. A subset of this 13-item tool is a module of four items that had previously been used as a standalone four-question screening tool in facilities in Zimbabwe.

The primary objectives of this study are as follows.

  1. To evaluate the performance of a lay cadre-administered four-item subset of the K2 HIV risk screening tool that matches the Zimbabwe evidence-based tool in predicting the HIV status of vulnerable children/adolescents represented by two populations: (a) K2 OVC beneficiaries and (b) children/adolescents attending health facilities.
  2. To identify additional items in the K2 HIV risk screening tool that could be added to the four-question subset to improve the tool's performance.
  3. To assess fidelity to the administration of the OVC HIV screening tool items through structured observations of community case workers in the K2 program.
  4. To assess the acceptability of OVC HIV risk screening and testing implemented in the community among OVC beneficiaries in the K2 program.
  5. To assess the acceptability and feasibility of integrating the OVC HIV screening tool with HIV testing among OVC community case workers in the K2 program.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
2 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Living in a household deemed to be at elevated HIV risk based on previously identified risk criteria
  • Attending a study health facility in two regions of Tanzania
  • Age 2-19 years

排除标准

  • Previously tested HIV-positive
  • History of antiretroviral treatment (ART)
  • Unable or unwilling to be consented
  • Age 5-19 years old, tested negative in past 6 months, and having no reported exposure to HIV through sexual contact (consensual, abuse) or through blood transfusion/needle injury.
  • Community care workers:
  • Inclusion criteria:
  • conducting HIV risk screening in OVC households as part of their role in the Kizazi Kipya project in the subset of study districts where structured observations and focus group discussions were conducted
  • Exclusion criteria:
  • unwilling to consent to the study

结局指标

主要结局

Specificity of HIV risk screening tool

时间窗: Within four weeks

Children/adolescents testing HIV negative on the tool who are truly HIV negative

Sensitivity of HIV risk screening tool

时间窗: Within four weeks

Children/adolescents testing HIV positive on the tool who are truly HIV positive

Positive predictive value

时间窗: Within four weeks

Proportion of children/adolescents testing positive on the tool who actually have HIV

Negative predictive value

时间窗: Within four weeks

Proportion of children/adolescents testing negative on the tool who do not actually have HIV

Acceptability of HIV risk screening tool

时间窗: Within six weeks

Examining the extent of reception of the screening tool by the OVC caregivers and the community case workers using a semi-structured questionnaire

Feasibility of HIV risk screening tool

时间窗: Within six weeks

Exploring the practicality of use of HIV risk screening tool through focus group discussions with community case workers

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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